Young-onset Colorectal Cancer Screening Based on Artificial Intelligence

NCT ID: NCT06342622

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-01-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

In this study, we aimed to develop, internally and temporally validate the machine learning models to help screen YOCRC bansed on the retrospective extracted Electronic Medical Records (EMR) data.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Diagnosis of young-onset colorectal cancer (YOCRC) has become more common in recent decades. Screening CRC among younger adults still remains a challenge. In this study, We plan to retrospectively extracte the relevant clinical data of young individuals who underwent colonoscopy from 2013 to 2022 using Electronic Medical Record (EMR). Multiple supervised machine learning techniques will be applied to distinguish YOCRC and non-YOCRC individuals, the above classifiers will be trained and internally validated in the training dataset and internal validation dataset admitted between 2013 and 2021, respectively. We will also assess the temporal external validity of the classifiers based on the admissions from 2022.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with young-onset colorectal cancer

Patients were diagnosed with young-onset colorectal cancer after receiving colonoscopy examination.

Using routine clinical data and machine learning models.

Intervention Type DIAGNOSTIC_TEST

This study used clinical data and machine learning model to screen young-onset colorectal cancer.

Patients without young-onset colorectal cancer

Patients were ruled out young-onset colorectal cancer after receiving colonoscopy examination.

Using routine clinical data and machine learning models.

Intervention Type DIAGNOSTIC_TEST

This study used clinical data and machine learning model to screen young-onset colorectal cancer.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Using routine clinical data and machine learning models.

This study used clinical data and machine learning model to screen young-onset colorectal cancer.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Newly diagnosed with CRC (YOCRC group)
* Age at 18-49 when diagnosis (YOCRC group)
* Never received any CRC-related treatment (YOCRC group)
* No CRC confirmed by colonoscopy or pathology (non-YOCRC group)
* Age at 18-49 (non-YOCRC group)

Exclusion Criteria

* Hospital stay less than 24 hours or with incomplete Complete Blood Count
* Patients with inflammatory bowel disease or hereditary CRC syndromes
* History of other types of primary malignant tumor and other reasons that made them unsuitable for enrollment
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dong Weiguo, PhD

Role: STUDY_CHAIR

Renmin Hospital of Wuhan University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

Zhen J, Li J, Liao F, Zhang J, Liu C, Xie H, Tan C, Dong W. Development and validation of machine learning models for young-onset colorectal cancer risk stratification. NPJ Precis Oncol. 2024 Oct 22;8(1):239. doi: 10.1038/s41698-024-00719-2.

Reference Type DERIVED
PMID: 39438621 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Weiguo Dong

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Young-Onset Colorectal Cancer
NCT02863107 ACTIVE_NOT_RECRUITING